* Bladder cancer marks first approval for AZ's durvalumab
* Big market is in lung cancer, where data due mid-year
* AstraZeneca sets durvalumab price at $15,000/month
(Adds analyst reaction, sales forecast, latest shares)
By Ben Hirschler and Divya Grover
May 2 U.S. regulators have approved
AstraZeneca's key immunotherapy drug durvalumab as a
treatment for bladder cancer, marking the first commercial green
light for a product the company hopes will go on to sell
billions of dollars.
The approval, while expected, marks a milestone for the
British company, which expects new cancer drugs to help revive
its fortunes following patent losses on older blockbuster
products like cholesterol pill Crestor and Nexium for heartburn.
Bladder cancer itself is a relatively small initial market,
where AstraZeneca is lagging behind rivals Bristol-Myers Squibb
and Roche whose immunotherapies are already
approved for the condition.
Durvalumab's big commercial opportunity lies in previously
untreated lung cancer, where key clinical trial results,
including with combination therapy, are due in June or July.
Leerink analyst Seamus Fernandez sees durvalumab capturing a
modest 10 percent of the estimated $2.3 billion global bladder
cancer market, while AstraZeneca in 2014 put the drug's peak
sales in all cancers at $6.5 billion, including combination use.
The U.S. Food and Drug Administration (FDA) said late on
Monday it granted accelerated approval to AstraZeneca's drug to
treat advanced bladder cancer in patients whose disease had
progressed despite chemotherapy.
The drug, which will have the brand name Imfinzi, works by
helping the body's immune cells kill cancer, offering an
alternative to toxic chemotherapy. While not without side
effects, such immuno-oncology treatment has the potential of
longer-lasting efficacy, although it comes at a high price.
AstraZeneca said the average wholesale acquisition cost of
durvalumab would be around $15,000 a month.
"This first approval for Imfinzi is an important milestone
in our return to growth," said AstraZeneca Chief Executive
The drug belongs to a new class of medicines called PD-L1
inhibitors that block a mechanism tumours use to evade detection
from the immune system.
It was approved by the FDA for use in patients with locally
advanced or metastatic urothelial carcinoma, by far the most
common form of bladder cancer, regardless of their status for
the amount of PD-L1 protein on their cancer cells.
Durvalumab won accelerated approval, which enables the use
of therapies for serious conditions to fill an unmet medical
need based on data the FDA believes is likely to predict a
clinical benefit. AstraZeneca is required to conduct trials to
confirm actual benefit to patients.
The FDA also approved a complementary diagnostic from Roche
that can be used with the drug to assess PD-L1 levels. Studies
have shown patients with high PD-L1 are more likely to do well
on durvalumab, although such a test is not required for its use.
Durvalumab is being tested on its own and also in
combination with another immune system-boosting therapy called
tremelimumab in various cancers.
The medicine is the latest immunotherapy to be approved by
the FDA, after nods for treatments developed against various
cancers by Bristol-Myers Squibb, Merck & Co, Roche, and
a collaboration between Germany's Merck KGaA and
AstraZeneca shares were up 0.3 percent in early London
trading on Tuesday.
(Editing by Susan Thomas and Jason Neely)